MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML SM STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number 155401105

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 09/06/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: attorney.

Event Description

Litigation alleges that patient experienced severe and constant pain and suffering, swelling, bursitis, lack of mobility and/or metallosis.Update ad 12 jun 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear and elevated metal ions.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML SM STATURE 10.5MM
• Type of Device: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8407823
• MDR Text Key: 138377835
• Report Number: 1818910-2019-86899
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295058205
• UDI-Public: 10603295058205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 155401105
• Device Lot Number: ZC9FGA000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 69